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What if the ability to repair a spinal cord injury became a reality in the next five years? The Spinal Injury Project at Griffith University, in partnership with the Perry Cross Spinal Research Foundation, is on the cusp of making this happen with a world-first Nerve Bridge Transplantation and Rehabilitation Human Clinical Trial. The Spinal Injury Project is part of the Clem Jones Centre for Neurobiology and Stem Cell Research and is directed by Professor James St John.
The Spinal Injury Project has a team of internationally recognised researchers based in state-of-the-art laboratories at the Gold Coast and Nathan campuses of Griffith University.
The project team is a leading group of research specialists including bioengineers, medical doctors, biological scientists and educators working together to develop this breakthrough treatment. The research was first initiated by the late Griffith University Professor Emeritus, and 2017 Australian of the Year, Alan Mackay-Sim almost 20 years ago. He was a pioneer in stem cell research and was successful in taking cells from the olfactory (nasal) system, transplanting them to the injury site and demonstrating that it was safe for use in humans.
Building on Professor Mackay-Sim’s incredible legacy, the ongoing research at Griffith University has made considerable improvements by developing a nerve bridge which improves how the cells are transplanted. The team has shown that the nerve bridges can repair spinal cord injury in preclinical work, and the clinical trial hopes to show that the nerve bridges can repair spinal cord injuries in humans.
This ground-breaking, world-first treatment involves the transplantation of the patient’s own olfactory cells from the nose into the spinal cord. The cells are formulated into nerve bridges which are transplanted directly into the injury site. To help stimulate regeneration and to reinforce connections that are made, intensive rehabilitation takes place before and after the cell transplantation.
The human clinical trial is anticipated to start in 2024 and aims to test the safety and efficacy of the nerve bridge transplantation and rehabilitation. The trial will have fifteen participants, ten who will undergo the nerve bridge transplantation and rehabilitation program and five participants who do only the rehabilitation program.
Participants will train intensively at a rehabilitation provider for 3 months at the start of the trial, and then 8 months at the end.
Throughout the trial functional, medical and psychological assessments will be conducted to determine the outcomes for each participant.
The Spinal Injury Project is reinventing and rethinking how cells can grow leading to the creation of new cell products. By combining advanced cell purification and engineering techniques the team has designed three-dimensional nerve bridges that allow neurosurgeons to precisely place the cells into the injury site. This dramatically improves the survival of the cells.
By enabling the cells to form stable connections within the nerve bridge prior to transplantation, the cells rapidly form a permissive bridge over the injury site that allows the spinal cord nerve cells to regenerate. Using the patient’s own cells greatly improves the safety of the treatment. This results in a treatment that has extremely rapid production times, is more effective and more affordable.
The cost to run this trial for fifteen participants is $8.5M. The Nerve Bridge Transplantation and Rehabilitation Human Clinical Trial is a truly inspirational endeavour. Through generous supporters like you, our funding partners, philanthropists, and our incredible fundraising community, we have raised $7.6M of the funding needed to commence the trial.
The Foundation and Griffith University will continue to work together to fundraise to ensure the funding required is raised in full.
The good news is that we are on track to commence the trial in 2024, subject to the relevant approvals being in place. The first approval is the human ethics which considers the safety and benefits of the treatment. The second approval is research governance which ensures that the medical safety team is appointed, contracts with all the providers and partners are in place, and that funding and insurance are available. Once the approvals are obtained, then advertising and recruitment will commence.
Thanks to the generous donations from the community and partner organisations including; Queensland Health, Nicola and Andrew Forrest, the Clem Jones Foundation, Brazil Family Foundation, Rhonda and Terry White and Griffith University, we have funding to proceed with the original plan to have fifteen people recruited to the trial, ten for the nerve bridge transplantation and rehabilitation program, plus five controls who will do just the rehabilitation program.
The Spinal Injury Project team is also seeking additional funding from various government and international funding agencies to expand the trial to 30 participants, but the outcomes are uncertain and won’t be known for many months. For this reason, the team has decided to commence the trial for the fifteen participants with the funding that has been raised so far.
To de-risk the trial, the Foundation with the support of our incredible donors, has already funded two rehabilitation clinical trials run by Griffith University and purchased an advanced microscope for the safety testing of the cells.
The Spinal Injury Project at Griffith University, in partnership with the Perry Cross Spinal Research Foundation, is on the cusp of making this happen with a world-first Nerve Bridge Transplantation and Rehabilitation Human Clinical Trial.
The project team is a leading group of research specialists including bioengineers, medical doctors, biological scientists and educators working together to develop this breakthrough treatment.
We invite you to join us today on this urgent and vital transformational journey of discovery to recovery for the tens of thousands of people in Australia and the millions across the world, who every day live their lives with the challenges of a spinal cord injury.
This ground-breaking, world-first treatment involves the transplantation of the patient’s own olfactory cells from the nose into the spinal cord. The cells are formulated into nerve bridges which are transplanted directly into the injury site. To help stimulate regeneration and to reinforce connections that are made, intensive rehabilitation takes place before and after the cell transplantation.
The human clinical trial is anticipated to start in 2024 and aims to test the safety and efficacy of the nerve bridge transplantation and rehabilitation. The trial will have fifteen participants, ten who will undergo the nerve bridge transplantation and rehabilitation program and five participants who do only the rehabilitation program.
Participants will train intensively at a rehabilitation provider for 3 months at the start of the trial, and then 8 months at the end.
Throughout the trial functional, medical and psychological assessments will be conducted to determine the outcomes for each participant.
The Spinal Injury Project is reinventing and rethinking how cells can grow leading to the creation of new cell products. By combining advanced cell purification and engineering techniques the team has designed three-dimensional nerve bridges that allow neurosurgeons to precisely place the cells into the injury site. This dramatically improves the survival of the cells.
By enabling the cells to form stable connections within the nerve bridge prior to transplantation, the cells rapidly form a permissive bridge over the injury site that allows the spinal cord nerve cells to regenerate. Using the patient’s own cells greatly improves the safety of the treatment. This results in a treatment that has extremely rapid production times, is more effective and more affordable.
The cost to run this trial for fifteen participants is $8.5M. The Nerve Bridge Transplantation and Rehabilitation Human Clinical Trial is a truly inspirational endeavour. Through generous
supporters like you, our funding partners, philanthropists, and our incredible fundraising community, we have raised $7.6M of the funding needed to commence the trial.
The Foundation and Griffith University will continue to work together to fundraise to ensure the funding required is raised in full.
The good news is that we are on track to commence the trial in mid-2024, subject to the relevant approvals being in place. The first approval is the human ethics which considers the safety and benefits of the treatment. The second approval is research governance which ensures that the medical safety team is appointed, contracts with all the providers and partners are in place, and that funding and insurance are available. Once the approvals are obtained, then advertising and recruitment will commence.
Thanks to the generous donations from the community and partner organisations including; Queensland Health, Nicola and Andrew Forrest, the Clem Jones Foundation, Brazil Family Foundation, Rhonda and Terry White and Griffith University, we have funding to proceed with the original plan to have fifteen people recruited to the trial, ten for the nerve bridge transplantation and rehabilitation program, plus five controls who will do just the rehabilitation program.
The Spinal Injury Project team is also seeking additional funding from various government and international funding agencies to expand the trial to 30 participants, but the outcomes are uncertain and won’t be known for many months. For this reason, the team has decided to commence the trial for the fifteen participants with the funding that has been raised so far.
To de-risk the trial, the Foundation with the support of our incredible donors, has already funded two rehabilitation clinical trials run by Griffith University and purchased an advanced microscope for the safety testing of the cells.
The Spinal Injury Project is in pursuit of a cure and is working with a laser focus towards the ultimate goal – a Human Clinical Trial.
This ground-breaking, world first project involves the transplantation of the patient’s own olfactory ensheathing cells (OECs) from the nose into the spinal cord. This experimental treatment has shown promise in previous human clinical trials and now needs further refinement.
The SIP team is reinventing and rethinking how cells can grow leading to the creation of new cell products. By combining advanced cell purification techniques and engineering, the team is designing three-dimensional nerve bridges that will help regenerate the spinal cord.
These 3D cell constructs use newly invented, award winning technology involving 3D printed templates. This methodology ensures patients receive optimal restoration of motor and sensory function and outcomes are as consistent as possible.
This approach has recently been successfully tested in pre-clinical models and has shown promising functional outcomes. This incredible approach has the potential to result in the first widely available treatment for spinal cord injury and it is being developed here in Australia.
Thank you for your interest in supporting the Perry Cross Spinal Research Foundation and the Spinal Injury Project at Griffith University and participating in this ground-breaking trial
It is important to note, we do not have any criteria or details about recruitment for this human clinical trial as yet, but to stay up to date with our research news please complete this secure form so we can add you to our database and send you regular newsletters.
Once news becomes available about the trial, we will email the database to advise them of the next steps. The recruitment will all be done independently from the Foundation and conducted by Griffith University who will host the Expression of Interest Application.
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